MAUDE Adverse Event Report: CONMED LARGO INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	KBL191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device kbl191, infinitytm anteromedial guide l 9/10mm, was being used during a lca reconstruction procedure on (b)(6) 2024 when it was reported, ¿when retracting the instrument from the joint (after performing femoral drill with kgp035) it disassembled.The distal part remained in articulation and was removed without difficulty.¿ there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device fell into the patient and was retrieved.The procedure was completed as planned without any delay.The device, kgp035, 3.5mm spade tip guide pin, was used during the procedure as a concomitant device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Examination of the returned used, item kbl191, confirmed the reported problem and found left tip detached from the guide shaft.Detached left tip was not returned for the evaluation.Examination found no issues with print critical dimensions.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive force.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: prior to use, remove all protective packaging and tip protector, if applicable.Inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken, or misaligned parts.Inspect instruments following use to ensure device integrity is intact.There should be no loose, broken, or missing parts.Do not use excessive force on instruments to avoid damage or breakage during use.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device kbl191, infinitytm anteromedial guide l 9/10mm, was being used during a lca reconstruction procedure on (b)(6) 2024 when it was reported, ¿when retracting the instrument from the joint (after performing femoral drill with kgp035) it disassembled.The distal part remained in articulation and was removed without difficulty.¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the device fell into the patient and was retrieved.The procedure was completed as planned without any delay.The device, kgp035, 3.5mm spade tip guide pin, was used during the procedure as a concomitant device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18864960
• Report Number: 1017294-2024-00025
• Device Sequence Number: 18213552
• Product Code: LXH
• UDI-Device Identifier: 30845854902305
• UDI-Public: (01)30845854902305(11)200106(10)1070282
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: KBL191
• Device Lot Number: 1070282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KGP035, 3.5MM SPADE TIP GUIDE PIN.; KGP035, 3.5MM SPADE TIP GUIDE PIN.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic